The following data is part of a premarket notification filed by Analogic Corp. with the FDA for C1 Series Patient Monitor, Models 863051, 863052, 863053, 863054; Optional Printer For Ci, Model M3925a.
Device ID | K041376 |
510k Number | K041376 |
Device Name: | C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A |
Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
Applicant | ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
Contact | Donald J Sherratt |
Correspondent | Donald J Sherratt ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
Product Code | MWI |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-05-24 |
Decision Date | 2004-07-20 |
Summary: | summary |